United States

The Jarvik 2000® Ventricular Assist Device with the post-auricular (behind-the-ear) connector is in clinical trials in the United States.

Much of medical research today is done in the laboratory. But in order to bring new medical treatments to the public, researchers must prove that what works in a test tube or lab animal also works in the human body. To do so requires clinical research: Controlled testing of new medical treatments in human subjects. The process for conducting such research is the clinical trial.

By the time a given treatment reaches clinical trials, it has already been highly-tested. Only those treatments which have sufficient scientific data to support the expectation that they will prove safe enough to merit human experimentation enter the clinical trial stage. Not surprisingly, the guidelines for conducting clinical trials are strict. Researchers must establish a protocol for every clinical trial conducted in the U.S. according to federal regulation. For each institution (hospital or medical center) involved in the research, the protocol of the trial is subject to the review of an Institutional Review Board (IRB), a committee of doctors, health professionals, administrators and community advocates who weigh the trial’s potential benefits against its risks and assess its ethical ramifications. Then, as the research progresses, the researchers report results regularly to certain federal agencies and publish findings in medical journals for the scrutiny of their peers.

So, while still under research, new medical treatments can reach the public through the clinical trial process. People who suffer a condition best addressed by a new medical device or drug under trial can volunteer to participate in a study and receive the treatment before it is commercially available. Volunteers who meet certain criteria can then be treated with the latest innovations in medical science.